Abstract: OBJECTIVE To develop the formulation and process of fexofenadine HCl and pseudoephedrine HCl extended- release tablets. METHODS Using single factor and orthogonal experiment design to study formulation of fexofenadine HCl layer and pseudoephedrine HCl layer, respectively. RESULTS The amount of disintegrant in the fexofenadine HCl layer, and the amounts of HPMC and Carbomer in the pseudopehedrine HCl layer are the key factors which have influences on the quality of tablets. The optimized formulation and process have been determined. CONCLUSION The quality of scale-up product which manufactured as per to the process meets the specification.